Disease (or Disorder); Intervertebral Disc, With Myelopathy (Manifestation) Clinical Trial
Official title:
NORSPAN Transdermal Patches Phase III Study In Non-Cancer Pain
| NCT number | NCT01476774 |
| Other study ID # | BP08-CN-001 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | November 17, 2011 |
| Last updated | July 7, 2015 |
| Start date | August 2009 |
This is a multiple-dose, double-blind, double-dummy, active-control, parallel-group, multi-center, safety and efficacy study.
| Status | Completed |
| Enrollment | 280 |
| Est. completion date | |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Males or females age are =20 ,=80 years. - Clinical diagnosis of musculoskeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1. - Subject is a current user of NSAIDS or paracetamol and reports a history of insufficient therapeutic benefit in musculoskeletal pain. - Subjects must record an 'average pain over the last week at study institution' score at primary pain site of = 4 on an 11-point numerical pain rating scale. - Subjects must be able to understands the study procedures and assessment, and agree to participate in the study by giving written informed consent. Exclusion Criteria: - Subjects who have been taking long-acting or short-acting opioid analgesic formulations within the last 4 weeks. - Subjects who have a current chronic disease(s) or who have a past history and high possibilities to relapse, in addition to their musculoskeletal pain, requiring frequent analgesic therapy. - Subjects with clinically unstable respiratory disease, dysfunction of the biliary tract, thyroid disease, adrenal cortical insufficiency, prostatic hypertrophy requiring intervention or renal artery stenosis. - Subject who have a past history of malignant neoplasm including leukemia and lymphoma. - Subjects with clinically unstable, active or symptomatic heart disease. - Subjects who have psychiatric disorder, uncontrolled seizures or convulsive disorder and so on. - Subjects who have a current or past (within 5 years) history of substance or alcohol abuse, or subjects who give a positive result in drug abuse test during the Screening Period. - Subjects scheduled for therapies within the study period which might effect study assessment. - Females who are pregnant, lactating or have a possibility of being pregnant. - Subjects with values > 2 times the upper limit of normal for AST or ALT or total bilirubin at visit 1 or who have severe impaired liver function. - Subjects with serum creatinine > 2 mg/dL at Visit 1 or who have severe impaired renal function. - Subjects with serum potassium < 3.5 mEq/L at Visit 1. - Subjects receiving hypnotics or other central nervous system (CNS) depressants. - Subjects receiving monoamine oxidase inhibitor (MAOI) within 2 weeks before screening. - Subjects who have a history of supersensitivity to study drug. - Known intolerance to and/or lack of effect of tramadol. - Subjects who participated in a clinical research study within 1 month of study entry. - Subjects who participated previously in a BTDS study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Investigational Site:Peking Union Medical Hospital (PUMC) | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Mundipharma (China) Pharmaceutical Co. Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary Efficacy Variable is the change of Pain Intensity (Patients Visual Analogue Scale) from baseline | 11 weeks | Yes |